BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VLOC PRODUCT

    MDR report key: 21129540 · Received January 10, 2025

    Report

    Report Number
    1219930-2025-00217
    Event Type
    Injury
    Date Received
    January 10, 2025
    Date of Event
    August 10, 2024
    Report Date
    January 10, 2025
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE: TITLE: PROGNOSIS OF LOWER URINARY TRACT SYMPTOMS AND FUNCTION AFTER ROBOT-ASSISTED RADICAL PROSTATECTOMY IN PATIENTS WITH PREOPERATIVE LOW BLADDER CONTRACTILITY: A PROSPECTIVE, OBSERVATIONAL STUDY JUNYA HATA , KANAKO MATSUOKA, HIDENORI AKAIHATA, KEI YAGINUMA, SATORU MEGURO, SEIJI HOSHI, TOMOYUKI KOGUCHI, YUICHI SATO, MASAO KATAOKA, SOICHIRO OGAWA, MOTOHIDE UEMURA, YOSHIYUKI KOJIMA YEAR:2024L 10.1002/NAU.25577. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A PROSPECTIVE STUDY INCLUDED 123 CASES OF ROBOT-ASSISTED RADICAL PROSTATECTOMY IN PATIENTS WITH LOW PREOPERATIVE BLADDER CONTRACTILITY. ANASTOMOSIS BETWEEN THE URETHRA AND BLADDER WAS ACHIEVED USING A RUNNING, 3-0 V-LOC SUTURE. INTEGRITY OF THE ANASTOMOSIS WAS CONFIRMED INTRAOPERATIVELY WITH INSTILLATION OF STERILE SALINE. CASES WERE EXCLUDED FROM ANALYSIS DUE TO POSTOPERATIVE COMPLICATIONS INCLUDING ANASTOMOTIC LEAKAGE, EXTERNAL URETHRAL STRICTURE, AND BLEEDING. ADDITIONAL COMPLICATIONS NOT DEVICE RELATED INCLUDE ILEUS. SEVERITY OF COMPLICATIONS AND INTERVENTIONS NECESSARY WERE NOT DESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511513 UNKNOWN VLOC PRODUCT SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM COVIDIEN LP LLC NORTH HAVEN UNKNOWN VLOC PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention